Cervical CancerNCT06149598
Coughing at Time of Cervical Biopsy
A study testing Coughing at the time of biopsy in people with Cervical Cancer and Cervical Dysplasia, run by Zydolab - Institute of Cytology and Immune Cytochemistry at 1 site in Germany.
Trial summary
To investigate the effect of coughing as an intervention to reduce pain in colposcopy guided biopsy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Cervical Cancer, Cervical Dysplasia, Colposcopy
- What is being tested?
- Coughing at the time of biopsy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 2 Jan 2024to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Completed 18 years of age
- written informed consent
- first colposcopy
- Clinically indicated colposcopy in case of an abnormal PAP smear or screening result and/or clinical abnormalities on the cervix uteri
- Necessity to take exactly two biopsies
Who cannot join
- Performing only one biopsy or more than two biopsies
- Performing an endocervical curettage (biopsy on the endocervix)
- Vaginal bleeding at the time of examination
- inadequate colposcopy
- Cervix uteri cannot be fully visualized
- Pregnancy
Show all 12Show fewer
- Patients with insufficient German language skills
- known anxiety disorders or depressive disorders
- Treatments already carried out on the cervix uteri
- Patients with a chronic or acute illness that influences the perception of pain or lead to permanent pain due to the disease itself
- psychosomatic illnesses
- Chronic use of pain medications or psychotropic medications or other medications that may have an influence on the sensation of pain
Trial locations and contacts
1 site in 1 country.
Germany1 site
Zydolab - Institute of Cytology and Immune Cytochemistry
Dortmund, North Rhine-Westphalia, 44137
About this study
Official title: Pain Reduction by Forced Coughing During Colposcopy Guided Cervical Biopsies: a Randomized Controlled Pilot Study
To investigate the effect of coughing as an intervention to reduce pain in colposcopy guided biopsy.
Read the detailed description
Colposcopy is a frequently practiced examination and Colposcopy guided biopsy causes pain. A few trials Investigated whether medical interventions such as the application of lidocaine led to reduced pain perception with inconsistent results. Only one trial compared coughing versus no coughing at the moment of biopsy. Although the results of this study did not lead to a significant difference between the two study arms, coughing seems to positively affect pain perception.
Since the patients are, in the best case, their own controls when it comes to subjective parameters such as pain perception, we prefer a cross-over rather than a parallel group design.
Based on the descriptive variables for pain during biopsy with and without cough determined in the pilot study, a case estimate for a prospective randomized cross-over study will be carried out. Since two biopsies are usually taken from the cervix in daily practice, the now planned pilot study in a cross-over design envisages the following two study arms:
- Group I: Patients cough during the first biopsy, they do not cough during the second biopsy
- Group II: Patients cough during the second biopsy, they do not cough during the first biopsy
The primary Outcome measure is the difference in the patients' perception of pain during the first and second biopsy on the cervix (ectocervix), measured using an 11-part numerical analogue scale (11-item NAS).
- Conditions
- Cervical Cancer, Cervical Dysplasia, Colposcopy, Pain Sensation, Cervical Biopsy
- Being tested
- Coughing at the time of biopsy
- Keywords
- cervical cancer, cervical dysplasia, cervical biopsy, pain, coughing, distraction
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Cervical Dysplasia, Pain, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coughing at the time of biopsyBehavioural
Patients are asked to cough or not to cough during cervical biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Coughing at the time of first biopsy | Experimental | Patients are asked to cough during the first biopsy. They should not cough during the second biopsy, and no additional interventions will be performed during the second biopsy. Receives: Behavioral: Coughing at the time of biopsy |
| Coughing at the time of second biopsy | Active comparator | Patients are asked to cough during the second biopsy. They should not cough during the first biopsy, and no additional interventions will be performed during the first biopsy. Receives: Behavioral: Coughing at the time of biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in pain between first and second biopsy
the difference in the patients' perception of pain during the first and second biopsy on the cervix (ectocervix), measured using an 11-part numerical analogue scale (11-item NAS). The numerical analogue scale consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (score 0) and 'pain as bad as it could be' (score 10). Women will be asked to mark her pain level on the line between the two endpoints.
Measured: Immediately after the examination
Secondary outcomes (6)
Pain perception before examination
the patients' perception of pain before examination, measured using an 11-part numerical analogue scale (11-item NAS). The numerical analogue scale consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (score 0) and 'pain as bad as it could be' (score 10). Women will be asked to mark her pain level on the line between the two endpoints.
Measured: Immediately before the start of the examination
Pain perception when inserting the specula
the patients' perception of pain at the moment of the insertion of the specula, measured using an 11-part numerical analogue scale (11-item NAS). The numerical analogue scale consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (score 0) and 'pain as bad as it could be' (score 10). Women will be asked to mark her pain level on the line between the two endpoints.
Measured: Immediately after the insertion of the specula
Pain perception when using acetic acid
the patients' perception of pain at the moment of the application of acetic acid, measured using an 11-part numerical analogue scale (11-item NAS). The numerical analogue scale consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (score 0) and 'pain as bad as it could be' (score 10). Women will be asked to mark her pain level on the line between the two endpoints.
Measured: Immediately after the application of acetic acid
Pain perception at first biopsy
the patients' perception of pain during the first biopsy, measured using an 11-part numerical analogue scale (11-item NAS). The numerical analogue scale consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (score 0) and 'pain as bad as it could be' (score 10). Women will be asked to mark her pain level on the line between the two endpoints.
Measured: Immediately after the first biopsy was performed
Pain perception at second biopsy
the patients' perception of pain during the second biopsy, measured using an 11-part numerical analogue scale (11-item NAS). The numerical analogue scale consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (score 0) and 'pain as bad as it could be' (score 10). Women will be asked to mark her pain level on the line between the two endpoints.
Measured: Immediately after the second biopsy was performed
Pain perception just after examination
the patients' perception of pain just after finishing the examination, measured using an 11-part numerical analogue scale (11-item NAS). The numerical analogue scale consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (score 0) and 'pain as bad as it could be' (score 10). Women will be asked to mark her pain level on the line between the two endpoints.
Measured: Immediately after the removal of the specula
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start2 Jan 2024
- Primary completion30 Apr 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zydolab - Institute of Cytology and Immune Cytochemistry
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. med. Ziad Hilal, Zydolab - Institute of Cytology and Immune Cytochemistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149598
- Sponsor's protocol ID
- COLPO-6
- Status last verified
- Feb 2025
- First submitted
- 19 Nov 2023
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Reduction by Forced Coughing During Colposcopy Guided Cervical Biopsies: a Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06149598
- Acronym / sponsor ID
- COLPO-6
- Conditions
- Cervical Cancer, Cervical Dysplasia, Colposcopy, Pain Sensation, Cervical Biopsy
- Keywords
- cervical cancer, cervical dysplasia, cervical biopsy, pain, coughing, distraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zydolab - Institute of Cytology and Immune CytochemistryUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of coughing as an intervention to reduce pain in colposcopy guided biopsy.
Detailed description
Colposcopy is a frequently practiced examination and Colposcopy guided biopsy causes pain. A few trials Investigated whether medical interventions such as the application of lidocaine led to reduced pain perception with inconsistent results. Only one trial compared coughing versus no coughing at the moment of biopsy. Although the results of this study did not lead to a significant difference between the two study arms, coughing seems to positively affect pain perception.
Since the patients are, in the best case, their own controls when it comes to subjective parameters such as pain perception, we prefer a cross-over rather than a parallel group design.
Based on the descriptive variables for pain during biopsy with and without cough determined in the pilot study, a case estimate for a prospective randomized cross-over study will be carried out. Since two biopsies are usually taken from the cervix in daily practice, the now planned pilot study in a cross-over design envisages the following two study arms:
- Group I: Patients cough during the first biopsy, they do not cough during the second biopsy
- Group II: Patients cough during the second biopsy, they do not cough during the first biopsy
The primary Outcome measure is the difference in the patients' perception of pain during the first and second biopsy on the cervix (ectocervix), measured using an 11-part numerical analogue scale (11-item NAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coughing at the time of first biopsy | Experimental | Behavioral: Coughing at the time of biopsyPatients are asked to cough during the first biopsy. They should not cough during the second biopsy, and no additional interventions will be performed during the second biopsy. |
| Coughing at the time of second biopsy | Active comparator | Behavioral: Coughing at the time of biopsyPatients are asked to cough during the second biopsy. They should not cough during the first biopsy, and no additional interventions will be performed during the first biopsy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Completed 18 years of age
- written informed consent
- first colposcopy
- Clinically indicated colposcopy in case of an abnormal PAP smear or screening result and/or clinical abnormalities on the cervix uteri
- Necessity to take exactly two biopsies
Key exclusion criteria (12 listed)
- Performing only one biopsy or more than two biopsies
- Performing an endocervical curettage (biopsy on the endocervix)
- Vaginal bleeding at the time of examination
- inadequate colposcopy
- Cervix uteri cannot be fully visualized
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coughing at the time of biopsyPatients are asked to cough or not to cough during cervical biopsy. | Behavioural | Coughing at the time of first biopsy, Coughing at the time of second biopsy |
Primary outcome
Difference in pain between first and second biopsy
Time frame: Immediately after the examination
the difference in the patients' perception of pain during the first and second biopsy on the cervix (ectocervix), measured using an 11-part numerical analogue scale (11-item NAS). The numerical analogue scale consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (score 0) and 'pain as bad as it could be' (score 10). Women will be asked to mark her pain level on the line between the two endpoints.
6 secondary outcomes
Pain perception before examination
Time frame: Immediately before the start of the examination
Pain perception when inserting the specula
Time frame: Immediately after the insertion of the specula
Pain perception when using acetic acid
Time frame: Immediately after the application of acetic acid
Pain perception at first biopsy
Time frame: Immediately after the first biopsy was performed
Pain perception at second biopsy
Time frame: Immediately after the second biopsy was performed
Pain perception just after examination
Time frame: Immediately after the removal of the specula
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Cervical Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coughing at the time of biopsy in people with Cervical Cancer and Cervical Dysplasia, run by Zydolab - Institute of Cytology and Immune Cytochemistry at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in pain between first and second biopsy (time frame: Immediately after the examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.